The Fit-One trial involves three prospective, randomized waitlist-controlled studies. These studies evaluate the effects of One Drop's digital therapeutics solution with and without Fitbit devices on the social cognitive, behavioral, and health outcomes of people with diabetes. Fit-One is being tested on adults with type 1 diabetes (T1D) of all weights, and adults with type 2 diabetes (T2D) or pre-diabetes that are overweight or obese (BMI ≥ 25).
Sub-study 1 (T2D). Eligible participants (N=300) with T2D, an A1c above 7.0% and Body Mass Index (BMI) ≥ 25 will be randomized to one of three groups. Participants assigned to group 1 (n=100) get One Drop's digital therapeutics solution (app, meter, and 'On Track' in-app coaching) and a Fitbit Ionic smartwatch and are asked to use both for 3 months. Participants assigned to group 2 (n=100) get One Drop's digital therapeutics solution and are asked to use it for 3 months. After 3 months, group 2 gets a Fitbit Ionic smartwatch. Finally, participants assigned to group 3 (n=100) are asked to manage their diabetes without an app, coach, or activity tracker for 3 months. After 3 months, group 3 gets One Drop's digital therapeutics solution (app, meter, and 'On Track' in-app coaching) and a Fitbit Ionic smartwatch (n=100). Sub-study 2 (T1D). Eligible participants (N=100) with T1D and an A1c above 7.0% will be randomized to one of two groups. Participants assigned to group 1 (n=50) get One Drop's digital therapeutics solution (app, meter, and 'On Call' in-app coaching) and a Fitbit Ionic smartwatch and are asked to use both for 3 months. Participants assigned to group 2 (n=50) get One Drop's digital therapeutics solution and are asked to use it for 3 months. After 3 months, group 2 gets a Fitbit Ionic smartwatch. Sub-study 3 (Pre-diabetes). Eligible participants (N=100) with pre-diabetes, an A1c between 5.7-6.4% and a BMI ≥ 25 will be randomized to one of two groups. Participants assigned to group 1 (n=50) get One Drop's digital therapeutics solution ('Revive' in-app coaching) and a Fitbit Charge 2 and are asked to use both for 3 months. Participants assigned to group 2 (n=50) get One Drop's digital therapeutics solution and are asked to use it for 3 months. After 3 months, group 2 gets a Fitbit Charge 2.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
Participants with T2D will use One Drop's digital therapeutics solution (app, meter, and 'On Track' in-app coaching) for 3 months
Participants with T1D will use One Drop's digital therapeutics solution (app, meter, and 'On Track' in-app coaching) for 3 months
Participants with pre-diabetes will use One Drop's digital therapeutics solution (app, meter, and 'Revive' in-app coaching) for 3 months
One Drop
New York, New York, United States
Hemoglobin A1c
Within- and between-group changes in central lab-assessed A1c measured at baseline and 3 months.
Time frame: 3 months
Weight
Within- and between-group changes in self-reported weight measured at baseline and follow-up(s). In sub-study 3, the Fitbit Aria Wi-Fi scale will assess weight at baseline, 4, 8, and 12 months post-baseline.
Time frame: 3 months (12 months for Sub-study 3)
Healthcare Utilization
Within- and between-group change in the number of emergency room visits and hospitalizations. This will be assessed with two self-reported items that ask: (1) How many times have you gone to the emergency room in the past 3 months? and (2) How many times have you been admitted to the hospital in the past 3 months?
Time frame: 3 months (12 months for Sub-study 3)
Diet
Within- and between-group diet changes. The Summary of Diabetes Self-Care Activities (SDSCA) general and specific diet subscales will measure self-reported 7-day diet behavior at baseline and follow-up(s). The One Drop app will collect daily and weekly diet behavior that's manually entered during the trial period.
Time frame: 3 months (12 months for Sub-study 3)
Physical Activity
Within- and between-group activity changes. The SDSCA exercise subscale will measure self-reported 7-day exercise behavior at baseline and follow-up(s). The One Drop app will also collect daily and weekly activity that's manually-entered and/or passively-collected via HealthKit, Google Fit, or a Fitbit tracker or smartwatch during the trial period.
Time frame: 3 months (12 months for Sub-study 3)
Medication Adherence
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TREATMENT
Masking
NONE
Enrollment
500
Within- and between-group medication adherence changes. The SDSCA medications subscale will measure self-reported 7-day medication adherence at baseline and follow-up(s). The One Drop app will also collect daily and weekly medication taking that's manually-entered into the app during the trial period.
Time frame: 3 months (12 months for Sub-study 3)
Self-Monitoring of Blood Glucose
Within- and between-group self-monitoring of blood glucose (SMBG) changes. The SDSCA SMBG subscale will measure self-reported 7-day SMBG at baseline and follow-up. During the trial period, the One Drop app will collect daily and weekly SMBG that's manually-entered and/or passively-collected via the One Drop \| Chrome Bluetooth-connected glucose meter.
Time frame: 3 months